title: Evaluation of safety and efficacy of a fixed olmesartan/amlodipine combination therapy compared to single monotherapies.
abstract: BACKGROUND
  Hypertension is known to be one of the main risk factors for cardiovascular disease.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of a fixed olmesartan/amlodipine (Olme/Amlo) combination in improving blood pressure control, lipid profile, insulin sensitivity and some inflammatory and insulin resistance markers. Two hundred and seventy-six hypertensive patients were randomly assigned to olmesartan 20 mg, amlodipine 10 mg or a single pill containing an Olme/Amlo combination 20/5 mg for 12 months. We evaluated after 6 and 12 months: body weight, body mass index (BMI), systolic and diastolic blood pressure (SBP and DBP, respectively), fasting plasma glucose (FPG), fasting plasma insulin (FPI), lipid profile, vaspin, visfatin, interleukins 8 and 10 (IL-8 and IL-10, respectively). Patients also underwent an euglycemic, hyperinsulinemic clamp.
  
  
  RESULTS
  Olme/Amlo combination was more effective in decreasing SBP, and DPB compared to single monotherapies after 12 months. Olme/Amlo combination, but not amlodipine, decreased FPG after 12 months. FPI and HOMA index were decreased, and M value increased by Olme/Amlo combination compared to olmesartan monotherapy, and to amlodipine monotherapy. Olme/Amlo significantly decreased IL-8 and IL-10 better than each monotherapy.
  
  
  CONCLUSIONS
  Olme/Amlo single pill combination can be a safe and effective option to reduce blood pressure, improve insulin sensitivity and decrease inflammatory markers.
authors.affiliation: University of Pavia, Department of Internal Medicine and Therapeutics, Pavia, Italy. giuseppe.derosa@unipv.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Derosa
authors.forename: Arrigo Francesco Giuseppe
authors.initials: AF
authors.lastname: Cicero
authors.forename: Anna
authors.initials: A
authors.lastname: Carbone
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Querci
authors.forename: Elena
authors.initials: E
authors.lastname: Fogari
authors.forename: Angela
authors.initials: A
authors.lastname: D'Angelo
authors.forename: Pamela
authors.initials: P
authors.lastname: Maffioli
mesh_terms: D054392:Adipokines / Q000097:blood; D017311:Amlodipine / Q000009:adverse effects* / Q000627:therapeutic use; D001786:Blood Glucose / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D007093:Imidazoles / Q000009:adverse effects* / Q000627:therapeutic use; D007249:Inflammation / Q000139:chemically induced; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance / Q000502:physiology; D016753:Interleukin-10 / Q000097:blood; D016209:Interleukin-8 / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D054392:Adipokines; D001786:Blood Glucose; C508606:CXCL8 protein, human; C508609:IL10 protein, human; D007093:Imidazoles; D007328:Insulin; D016209:Interleukin-8; D008055:Lipids; D013777:Tetrazoles; D016753:Interleukin-10; D017311:Amlodipine; C437965:olmesartan